NCT00505037

Brief Summary

To evaluate the superiority to placebo, dose-responsibility and safety.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

March 22, 2011

Status Verified

March 1, 2011

Enrollment Period

11 months

First QC Date

July 18, 2007

Last Update Submit

March 21, 2011

Conditions

HyperphosphatemiaChronic Kidney Disease

Keywords

ASP1585Renal DialysisChronic Kidney DiseaseHyperphosphatemia

Outcome Measures

Primary Outcomes (1)

  • Change in serum phosphorus

    4 weeks

Secondary Outcomes (5)

  • Change in serum phosphorus level by time

    Up to 4 weeks

  • Percent of patients meeting the target range of serum phosphorus (3.5-6.0 mg/dL) and achieving time

    4 Weeks

  • Change in corrected serum Ca level

    4 weeks

  • Change in Ca×P

    4 weeks

  • Change in intact PTH

    4 weeks

Study Arms (5)

ASP1585 dose #1

EXPERIMENTAL
Drug: ASP1585

ASP1585 dose #2

EXPERIMENTAL
Drug: ASP1585

ASP1585 dose #3

EXPERIMENTAL
Drug: ASP1585

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Sevelamer hydrochloride

ACTIVE COMPARATOR
Drug: Sevelamer hydrochloride

Interventions

ASP1585DRUG

Oral

ASP1585 dose #1ASP1585 dose #2ASP1585 dose #3
PlaceboDRUG

Oral

Placebo
Sevelamer hydrochlorideDRUG

Oral

Sevelamer hydrochloride

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stable CKD patients who are currently on hemodialysis three times a week for at least 12 weeks prior to the acquisition of informed consent
  • Patients on stable dose(s) of phosphate binder(s) for at least 28 days prior to the acquisition of informed consent.
  • Patients on stable dose(s) of Vitamin D or calcitonin agent for at least 28 days prior to the acquisition of informed consent, in case patients are treated by those agents

You may not qualify if:

  • History of major gastrointestinal surgery, or swallowing disorders, bowel obstruction, hemorrhagic gastrointestinal lesion
  • Continuous severe constipation/diarrhea.
  • History of parathyroid intervention \[parathyroidectomy（PTx），percutaneous ethanol injection therapy（PEIT）etc.\] within 1 year of the acquisition of informed consent
  • Diet restriction such as fasting and/or excessive dieting
  • Uncontrolled hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Unknown Facility

Chugoku, Japan

Location

Unknown Facility

Chūbu, Japan

Location

Unknown Facility

Kansai, Japan

Location

Unknown Facility

Kanto, Japan

Location

Unknown Facility

Kyushu, Japan

Location

Unknown Facility

Shikoku, Japan

Location

Related Publications (2)

  • Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.

    PMID: 40576086DERIVED

  • Akizawa T, Origasa H, Kameoka C, Kaneko Y, Kanoh H. Dose-finding study of bixalomer in patients with chronic kidney disease on hemodialysis with hyperphosphatemia: a double-blind, randomized, placebo-controlled and sevelamer hydrochloride-controlled open-label, parallel group study. Ther Apher Dial. 2014 Jun;18 Suppl 2:24-32. doi: 10.1111/1744-9987.12202.

    PMID: 24975892DERIVED

MeSH Terms

Conditions

HyperphosphatemiaRenal Insufficiency, Chronic

Interventions

Sevelamer

Condition Hierarchy (Ancestors)

Phosphorus Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PolyaminesAminesOrganic Chemicals

Study Officials

  • Use Central Contact

    Astellas Pharma Inc

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 18, 2007

First Posted

July 20, 2007

Study Start

October 1, 2007

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

March 22, 2011

Record last verified: 2011-03

Locations

JP(6)